Can a 10-Day antifungal course beat the standard 14 days?
NCT ID NCT07788586
First seen Aug 26, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This trial investigates whether a shorter course of the antifungal drug caspofungin is as effective as the standard 14-day treatment for uncomplicated candidemia, a bloodstream infection caused by Candida yeast. Adults with this infection will be randomly assigned to receive either 10 or 14 days of treatment, and researchers will compare the rates of infection recurrence. The goal is to see if shorter treatment can reduce side effects, drug resistance, and costs without compromising patient outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- caspofungin
- What this could lead to
- If successful, this could show that a shorter course of antifungal treatment is just as effective, reducing side effects, drug resistance, and healthcare costs.
- What could go wrong
- This is a phase 4 trial, but the outcome is not guaranteed. Shorter treatment might not be as effective for everyone, and there is a risk of recurrent infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 420 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Participants ≥18 years on the day of informed consent. * 2\. Written informed consent by participant, according to applicable guidelines and laws. * 3\. For female participants of child-bearing potential only: willingness to practice highly effective contraception or abstinence for the duration of the trial, i.e. until 30 days after end of study treatment. Highly effective contraception methods include sterilization, combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. In case of nausea, diarrhoea or vomiting, oral contraception cannot be used; a non-oral highly effective method of contraception must be used instead. * 4\. Treatment with caspofungin for candidemia, initially proven by Candida-positive blood culture. * 5\. Uncomplicated candidemia defined as follows: * a. 7 consecutive days of caspofungin treatment after documented clearance of candidemia, i.e. caspofungin treatment on Day -7 to Day -1 prior to study treatment. Documented clearance of candidemia is defined as first (since diagnosis of candidemia) Candida-negative blood-culture on Day -7 AND no Candida-positive blood cultures from Day -6 to Day -1. * b. Treatment is planned for another 7 days, i.e. for the entire duration of study treatment from Day 1 to Day 7. Please note there is no Day 0 in this study. Day -1 is directly followed by Day 1. * c. Less than 120 hours between the initial Candida-positive blood culture and the first Candida-negative blood-culture. * d. Source control for candidemia as follows: * Any central venous access device (e.g., central venous catheter, peripherally inserted central catheters, Shaldon catheters, Hickman and Broviac lines, or implanted port systems) must have been removed/replaced within 48 hours after the start of caspofungin treatment when candidemia was first diagnosed. * Any implantable cardiac electronic device, ventricular assist device, extracorporeal membrane oxygenation support system, or indwelling intravascular foreign body must have been removed/replaced within 48 hours after the start of caspofungin treatment when candidemia was first diagnosed. * Any intraabdominal candidiasis (e.g., intraabdominal abscess, peritonitis) must have been treated successfully within 5 days after start of treatment (caspofungin with or without surgery) when candidemia was first diagnosed. Exclusion Criteria: * 1\. Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -1. * 2\. Complicated candidemia defined by any of the following: * a. History of candidemia within 3 months prior to the current candidemia episode. * b. History or current presence of extra-abdominal deep-seated candidiasis, i.e. central nervous system infection, chorioretinitis, endophthalmitis, intravascular infection, endocarditis, renal abscess, osteomyelitis, or joint infection. * c. History of intra-abdominal candidiasis within 3 months prior to the current candidemia episode. Only exception: a very first episode of intra-abdominal candidiasis has been treated successfully within 5 days after the initial diagnosis of the current candidemia episode. * d. Candidemia caused by echinocandin-resistant Candida isolate. * 3\. Hematological malignancy without remission. * 4\. Allogeneic hematopoietic stem-cell transplantation within 1 year prior to screening. * 5\. Acute graft-versus-host disease grade III or IV. * 6\. Hypersensitivity to caspofungin or any of the excipients. * 7\. Ongoing glucocorticosteroids ≥0.3 mg/kg of prednisone equivalent per day at the initial diagnosis of the current candidemia episode with a planned cumulative administration of more than 3 weeks or ongoing administration of more than three weeks. * 8\. Concomitant rifampin/rifampicin, phenytoin, carbamazepine, efavirenz or nevirapine during study participation. * 9\. Absolute neutrophil count \<0.5 G/L at screening. * 10\. Absolute neutrophil count \<0.5 G/L of any duration expected during study treatment. * 11\. Child-Pugh score \>9 at screening. * 12\. Pregnant women and breastfeeding mothers. Prior to enrolment, pregnancy must be ruled out by a negative blood pregnancy test for all women of child-bearing potential. * 13\. Active intravenous illicit drug use. * 14\. Administration of an investigational drug (i.e. not yet authorized) * a. Within 30 days before the first dose of study treatment in this trial OR * b. Within five half-lives before the first dose of study treatment in this trial whichever is longer. An investigational drug is defined as a drug not authorized for any indication in the country where this trial is conducted. * 15\. Previous participation in this trial. * 16\. Person who is in a relationship of dependence/employment with the Sponsor or the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
24 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
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Klinikum Oldenburg
Oldenburg, 26133, Germany
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Klinikum der Medizinischen Hochschule Hannover
Hanover, 30625, Germany
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Klinikum der Technischen Universität München (TUM Klinikum)
München, 81675, Germany
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LMU Klinikum
München, 81377, Germany
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Uniklinik Köln
Cologne, 50937, Germany
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Universitätsklinik Magdeburg A. ö. R. / Medizinische Fakultät der Otto-von Guericke Universität Magdeburg
Magdeburg, 39120, Germany
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Universitätsklinikum Aachen
Aachen, 52074, Germany
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Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität Dresden
Dresden, 01307, Germany
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Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
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Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
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Universitätsklinikum Freiburg
Freiburg im Breisgau, 79110, Germany
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Universitätsklinikum Gießen und Marburg
Giessen, 35392, Germany
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Universitätsklinikum Halle (Saale)
Halle, 06120, Germany
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
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Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
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Universitätsklinikum Jena
Jena, 07747, Germany
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Universitätsklinikum Leipzig
Leipzig, 04103, Germany
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Universitätsklinikum Münster
Münster, 48149, Germany
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Universitätsklinikum Regensburg
Regensburg, 93053, Germany
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Universitätsklinikum Ulm
Ulm, 89081, Germany
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Universitätsklinikum Würzburg
Würzburg, 97080, Germany
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Universitätsklinikum des Saarlandes
Homburg (Saar), 66421, Germany
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Universitätsmedizin Göttingen
Göttingen, 37075, Germany
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